The protection of human health and the environment requires that due attention be given to controlling risks from the deliberate release into the environment of genetically modified organisms (GMOs). The European Union (EU) has consequently adopted a legislative framework on the deliberate release of GMOs into the environment and the placing of GMOs on the market in accordance with the precautionary principle. This framework aims to improve the efficiency and transparency of the authorisation procedures. It also contributes to the establishment of a common methodology for risk assessment and a safety mechanism. The new legislative framework introduces mandatory public consultation and GMO labelling.

ACT

Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. [See amending act(s)].

SUMMARY

The main aim of this Directive is to make the procedure for granting consent for the deliberate release and placing on the market of genetically modified organisms (GMOs) more efficient and more transparent, to limit such consent to a period of ten years (renewable) and to introduce compulsory monitoring after GMOs have been placed on the market.

It also provides for a common methodology to assess case-by-case the risks for the environment associated with the release of GMOs (the principles applying to environmental risk assessment are set out in Annex II to the Directive), common objectives for the monitoring of GMOs after their deliberate release or placing on the market, and a mechanism allowing the release of the GMOs to be modified, suspended or terminated where new information becomes available on the risks of such release.

Public consultation and GMO labelling are made compulsory under the new Directive. The system of exchange of information contained in notifications, set up under Directive 90/220/EEC, is maintained. The Commission is obliged to consult the competent scientific committees on any question which may affect human health and/or the environment. It may also consult ethical committees. The Directive requires registers to be established for the purpose of recording information on genetic modifications in GMOs and on the location of GMOs. Rules on the operation of these registers are laid down in Decision 2004/204/EC (see related acts).

Every three years, the Commission must publish a summary of the measures taken in the Member States to implement the Directive, and a report on experience with GMOs placed on the market. This report should include a separate chapter on the socio-economic advantages and disadvantages of each type of GMO authorised to be placed on the market, taking due account of the interests of farmers and consumers (the first report was due to be published in 2003). An annual report on ethical issues will also be published. The Directive invited the Commission to present a proposal for implementing the Cartagena Protocol on biosafety, which led to the adoption of Regulation (EC) No 1946/2003 on transboundary movements of genetically modified organisms.

Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms will be repealed by the present Directive from 17 October 2002.

Commission Decision 2005/463/EC of 21 June 2005 establishing a network group for the exchange and coordination of information concerning coexistence of genetically modified, conventional and organic crops [Official Journal L 164 of 24.6.2005].

Commission Decision 2004/204/EC of 23 February 2004 laying down detailed arrangements for the operation of the registers for recording information on genetic modifications in GMOs, provided for in Directive 2001/18/EC of the European Parliament and of the Council [Official Journal L 65 of 3.3.2004].
Pursuant to Directive 2001/18/EC, the Commission must establish one or more registers recording information on genetic modifications in GMOs. The Decision specifies that the registers will contain information accessible to the public, and information accessible only to the Member States, the Commission and the European Food Safety Authority. The information which must be recorded includes:

detailed information on the person responsible for the deliberate release or the placing on the market;

general information concerning the GMO(s) (the commercial and scientific names, the Member State concerned, the decision to authorise the GMO, etc.);

information on the DNA inserted into the GMO;

information on detection and identification tools;

information on the lodging, storage and supply of samples.

Commission Decision 2003/701/EC of 29 September 2003 establishing, pursuant to Directive 2001/18/EC of the European Parliament and of the Council, a format for presenting the results of the deliberate release into the environment of genetically modified higher plants for purposes other than placing on the market Official Journal L 254 of 8.10.2003.

Summary notification format

Council Decision 2002/813/EC of 3 October 2002 establishing, pursuant to Directive 2001/18/EC of the European Parliament and of the Council, the summary notification information format for notifications concerning the deliberate release into the environment of genetically modified organisms for purposes other than for placing on the market Official Journal L 280 of 18.10.2002.

Council Decision 2002/812/EC of 3 October 2002 establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council the summary information format relating to the placing on the market of genetically modified organisms as or in products Official Journal L 280 of 18.10.2002.

Explanatory notes on the annexes

Council Decision 2002/811/EC of 3 October 2002 establishing guidance notes supplementing Annex VII to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC Official Journal L 280 of 18.10.2002.

Commission Decision 2002/623/EC of 24 July 2002 establishing guidance notes supplementing Annex II to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC Official Journal L 200 of 30.7.2002.

Reports

Second report from the Commission to the Council and the European Parliament of 5 March 2007 on the experience of Member States with GMOs placed on the market under Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms [COM(2007) 81 final - Not published in the Official Journal].
Between October 2002 and October 2005, 13 applications to place genetically modified plants on the market were submitted in 8 Member States and led to the authorisation of 5 products:

NK603 maize from Monsanto Europe S.A;

MON863 maize from Monsanto Europe S.A;

GT73 oilseed rape from Monsanto Europe S.A;

1507 maize from Pioneer Hi-Bred International INC and Mycogen Seeds;

MON863 x MON810 maize from Monsanto Europe S.A.

Moreover, in the same period, 245 applications for the release of GMOs for purposes other than for placing on the market (e.g. for research purposes) submitted to 13 Member States led to 191 authorisations (with 23 applications pending in October 2005).

Those Member States which have handled applications are generally positive about their experience with the implementation of the Directive, despite a number of technical issues which have yet to be adequately addressed. Other stakeholders have tended to be less positive in their assessment of the Directive. Some Member States have called for more guidance on specific aspects of environmental risk assessment and increased harmonisation of the process of release for research purposes. The majority of Member States has emphasised the need for a legal instrument establishing seeds' thresholds.

Report from the Commission to the Council and the European Parliament of 31 August 2004 on the experience of Member States with GMOs placed on the market under Directive 2001/18/EC and incorporating a specific report on the operation of parts B and C of the Directive [COM(2004) 575 - not published in the Official Journal].
This report concerns only 15 Member States as the reference period for this report ended before the accession of the new Member States (1 May 2004). The vast majority of GMOs that have been developed for deliberate release are transgenic crop plants, modified for tolerance to certain herbicides or resistance to certain insect pests. Despite the fairly limited experience gained since this Directive entered into force, the report stresses that the Directive and the relevant Regulations (see below) help to increase confidence in the legislative framework and to increase the predictability of the decision-making process.